U.S. Seeks to Develop Late-Stage Smallpox Antivirals

The etiological agent responsible for smallpox disease, Variola viridae (VARV) is responsible for the deaths of hundreds of millions of people throughout history.

While smallpox disease is eradicated, repositories of VARV remain, and it is still considered one of the most dangerous human pathogens as it is highly communicable and carries exceptionally high morbidity.

While there is a licensed smallpox vaccine stockpiled for the pre-exposure prophylaxis against smallpox, there are currently no approved therapeutic antivirals for the treatment of symptomatic smallpox. The Biomedical Advanced Research and Development Authority (BARDA) is seeking to procure smallpox therapeutic antiviral agents for the Strategic National Stockpile that can be used in the event of an outbreak to treat symptomatic patients.

It is anticipated that a formal Request for Proposals may be available electronically through the FedBizOpps website sometime in February 2018 for 45 days with proposals being due in April 2018. One contract award with both cost reimbursement and firm-fixed CLINs will be awarded by July 2018. The anticipated base period of performance for any resultant contract(s) will be for a total of 60 months and up to 10 years with options if exercised.

All proposals submitted to any future solicitations shall have evidence of two formulations of the antiviral (parenteral and nonparenteral), an active FDA IND or licensed product with completed phase I trials for both products, evidence of efficacy in at least two animal models accepted by the FDA for the evaluation of a smallpox medical countermeasure, and the ability of the Offeror to deliver at least one formulation to the Strategic National Stockpile upon contract award (e.g. FDA approval, pre-EUA IND on file).

Additional details and requirements will be described in the forthcoming solicitation.